Phosphate Microvascular Study

Veterans Medical Research Foundation

Status: Unknown

Conditions: End Stage Renal Disease; Hyperphosphatemia

Treatments: Other: Withholding standard phosphate binder

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03594539

VAH170095

Details and patient eligibility

About

Elevated phosphate concentrations in the blood have been associated with multiple negative health outcomes in patients with chronic kidney disease as well as in the general population. These negative outcomes include an increased risk of vascular complications like heart attack and stroke. While complications like heart attack and stroke reflect obstructive disease in large blood vessels, recent evidence suggests that elevated phosphate concentrations may first lead to disease in small blood vessels.

This single site clinical trial will randomize 20 veterans with end stage renal disease on hemodialysis to either a phosphate binder or placebo and evaluated for changes in their microvascular function using laser-Doppler flowmtery and nail-fold capillaroscopy.

Full description

Project Background: Recent studies have suggested that increased serum phosphate and phosphate intake may acute impair microvascular blood flow. However, this has never been directly tested using imaging techniques that directly measure microvascular flow. The end-stage renal disease population on hemodialysis at the VA San Diego is an ideal population to evaluate this effect.

Project Question: Does reduction of serum phosphate through the use of a phosphate binder (lanthanum carbonate) increase microvascular blood flow in persons with ESRD? Project Methods: The investigators propose a 4 week, randomized, double-blinded, placebo controlled, single-center, crossover trial. Participants will have their microvascular function assessed at the baseline of the study using laser-Doppler flowmetry and nail-fold capillaroscopy. They will then be randomized to either lanthanum carbonate or placebo for 2 weeks. Microvascular measurements will be repeated at the end of the 2 week period. Participants will then cross-over to the other study arm. After 2 weeks in the other study arm, they will have microvascular measurements repeated and the trial will then be complete. The primary outcome of the study will be the % change in skin blood flow after heating from 31 degrees Celsius to 44 degrees Celsius. This will be compared within each individual after they complete each arm of the study. Changes seen on nail-fold capillaroscopy, acceptability, safety, and adherence will be key secondary outcomes.

Enrollment: 20 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ESRD on hemodialysis (HD) for >90 days.
• Age >21.
• Capacity to understand and sign informed consent as assess by principal investigator.
• On a phosphate binder with stable dose for >2 weeks.
• Serum phosphate at screening visit of <7.0.

Exclusion criteria

• Pregnancy.
• Actively breastfeeding.
• Use of oral contraceptives.
• Inability to take oral medications.
• History of medication non-compliance as assessed by the treating physician.
• Patients currently enrolled in another trial.
• Planned or expected surgical procedure during study period.
• Planned or expected hospitalization during study period.
• Corrected serum calcium greater than 10.2 mg/dl.
• Serum intact PTH >1000 pg/ml
• Albumin < 3 g/dl.
• Allergy or intolerance to lanthanum carbonate.
• Principal investigator deems patient to be unsuitable.
• Non-English speaking persons. (Study performed at VA, therefore do not anticipate this represents a significant portion of the population).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Standard

No Intervention group

Description:

Participants will have their hyperphosphatemia managed with lanthanum carbonate 1 g with meals and 500 mg with snacks as per typical care, for 2 weeks.

Intervention

Placebo Comparator group

Description:

Participants will take a placebo instead of standard care with a phosphate binder, for 2 weeks.

Treatment:

Other: Withholding standard phosphate binder